Apparatus useful for positioning a device on an endoscope

ABSTRACT

A medical apparatus and method useful for positioning a device, such as an endcap, on an end of an endoscope, is disclosed. The apparatus can exert a pulling force on the endoscope through the endcap while a pushing force is applied to the endcap. The apparatus can be used to press an endcap onto the distal end of an endoscope without grasping by hand a sheath in those applications where the endoscope is disposed in a sheath.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority to the following patent applications,which are hereby incorporated by reference: U.S. Ser. No. 10/440,957(published as US 2004/0230095); 10/440,660 (published as US2004/0230096); and U.S. Ser. No. 10/440,956 (published US 2004/0230097);each filed May 16, 2003.

This application claims priority to and incorporates by reference U.S.patent application “Medical Instrument Having a Guidewire and an Add-toCatheter”, filed May 12, 2005 in the name of Long et al. having a Ser.No. 11/128,108.

FIELD OF THE INVENTION

The present invention is related generally to medical devices and moreparticularly to devices and methods useful in endoscopic procedures.

BACKGROUND OF THE INVENTION

Minimally invasive procedures are desirable because such procedures canreduce pain and provide relatively quick recovery times as compared withconventional open medical procedures. Many minimally invasive proceduresare performed with an endoscope (including without limitationlaparoscopes). Such procedures permit a physician to position,manipulate, and view medical instruments and accessories inside thepatient through a small access opening in the patient's body.Laparoscopy is a term used to describe such an “endosurgical” approachusing an endoscope (often a rigid laparoscope). In this type ofprocedure, accessory devices are often inserted into a patient throughtrocars placed through the body wall.

Still less invasive treatments include those that are performed throughinsertion of an endoscope through a natural body orifice to a treatmentsite. Examples of this approach include, but are not limited to,cystoscopy, hysteroscopy, esophagogastroduodenoscopy, and colonoscopy.Many of these procedures employ the use of a flexible endoscope duringthe procedure. Flexible endoscopes often have a flexible, steerablearticulating section near the distal end that can be controlled by theuser by utilizing controls at the proximal end.

Some flexible endoscopes are relatively small (1 mm to 3 mm indiameter), and may have no integral accessory channel (also calledbiopsy channels or working channels). Other flexible endoscopes,including gastroscopes and colonoscopes, have integral working channelshaving a diameter of about 2.0 to 3.5 mm for the purpose of introducingand removing medical devices and other accessory devices to performdiagnosis or therapy within the patient. As a result, the accessorydevices used by a physician can be limited in size by the diameter ofthe accessory channel of the scope used. Additionally, the physician maybe limited to a single accessory device when using the standardendoscope having one working channel.

Certain specialized endoscopes are available, such as large workingchannel endoscopes having a working channel of 5 mm in diameter, whichcan be used to pass relatively large accessories, or to providecapability to suction large blood clots. Other specialized endoscopesinclude those having two working channels. One disadvantage of suchlarge diameter/multiple working channel endoscopes can be that suchdevices can be relatively expensive. Further, such largediameter/multiple working channel endoscopes can have an outer diameterthat makes the endoscope relatively stiff, or otherwise difficult tointubate.

Various references describe methods or systems related to an endoscope,such as for example: U.S. Pat. No. 5,025,778, Silverstein; U.S. Pat. No.4,947,827, Opie; US 2002/107530 published Aug. 8, 2002 in the name ofSauer; U.S. Pat. No. 6,352,503, Matsui. One disadvantage of knownsystems is the potential for the distal end of a device used externallyof an endoscope to move, which may cause the accessory to lack precisionor the ability to be maintained within a desired field of view of theimaging capability of the endoscope.

WO 00/48506 published Aug. 24, 2000 in the name of Herrmann discloses adeformable endoscope with at least one supplementary device. The unitcomprising the endoscope and the supplementary device is said to have anon-round cross-section. Such a non-circular endoscope may bedisadvantageous from the point of view of cost, complexity, or ease incleaning/sterilization. For instance, a standard endoscope with asmooth, substantially-circular cross section can be relatively easy tosanitize and clean.

WO 00/48506 published Aug. 24, 2000 in the name of Kortenbach, disclosesmethods and devices for delivering a medical instrument over theexterior of an endoscope to allow the use of instruments too large tofit through the lumena of the endoscope. Kortenbach discloses a collarfor use with an endoscope, resilient straps, a flexible sheath having areclosable seam, flexible polymer extrusions, and a floppy tangentialsheath defining a lumen having an irregular (collapsible) cross section.Kortenbach also discloses a track with an inverted T configuration.

Endoscopes may also be used with feeding tubes. For instance, it isknown to advance a feeding tube through an internal channel of anendoscope. It is also known to advance a feeding tube together with anendscope, such as by holding the distal end of the feeding tube with apair of forceps extending from a distal end of the endoscope, and“dragging” the feeding tube along the outside of the endoscope whileadvancing the endoscope to a desired location.

Still, scientists and engineers continue to seek improved devices andmethods for the introducing medical devices into the gastro-intestinaltract, including improved devices and methods for placing feeding tubesin patients.

SUMMARY OF THE INVENTION

The present invention provides methods and devices useful with variousmedical procedures, including without limitation methods and devicesuseful with endoscopes, methods and devices employed through naturallyoccurring body orifices, and methods and devices related to placement offeeding tubes. For instance, in one embodiment, the present inventioncan be used to quickly and consistently place an accessory, such as afeeding tube, in a desired location, such as in the stomach or thejejunum, and such that the device stays in the desired position duringremoval of the endoscope. In certain embodiments, the present inventioncan be employed to reduce the number of intubations needed for certainprocedures, such as the number of intubations needed to place a feedingtube. In certain embodiments, the present invention can also be employedto reduce the number of steps required in certain medical procedures,such as by reducing the oral to nasal transfer steps in feeding tubeinstallation, reducing the number of times tools or devices are switchedor deployed in the body, reducing the number of hands required toperform a procedure, and/or reducing the number of times the medicalprofessional must change hand position during a procedure.

In one embodiment, the present invention provides an apparatus forpositioning a device, such as an endcap, on an end of an endoscope. Theapparatus can include a first component for applying a force to theendcap; and a second component operatively associated with the firstcomponent and movable with respect to the first component. The secondcomponent can apply a force to the endoscope through an opening in thedevice. In one embodiment, the first component applies a pushing forceon a distal face of the endcap, simultaneously with the second componentapplying a pulling force to the endoscope. In one embodiment, theapparatus includes a component that can be selectively expandable withina working channel of the endoscope to provide a pulling force on theendoscope. In another embodiment, the apparatus includes a loadingelement (which can be disposable and formed of a lightweight polymericmaterial) which has a first end sized to pass through the endcap, and asecond end adapted to releasably engage the distal end of the endoscope.The loading element can have a plurality of resilient prongs forreleasably engaging the distal end of the endoscope.

In certain embodiments, the invention can be employed with respect toprocedures involving Percutaneous Endoscopic Gastrostomy (PEG) tubesand/or Jejunal Enteral Tube through a Percutaneous EndoscopicGastrostomy (JET PEG) procedures.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a schematic illustration of an endoscopic sheath and track.

FIG. 1A is a schematic illustration of an endoscope inserted into ahandle having a hinged latch in an open configuration.

FIG. 1B is a schematic illustration similar to that of FIG. 1A showingthe hinged latch in a closed position and feeding tube and carrier beingadvanced on a track.

FIG. 2 is a schematic illustration of the distal end of the sheath ofFIG. 1 showing a carrier being advanced on the track.

FIG. 2A is a schematic isometric illustration showing the proximal endof the endcap.

FIG. 3 illustrates different sections of a track disposed on a sheath.

FIG. 4 is a top view illustration of a portion of a track.

FIG. 5 is a cross-sectional illustration of a track supported on asheath (it being understood that the sheath may be formed of a thin filmthat would not maintain the circular configuration shown in FIG. 5absent an internal member, such an endoscope, being disposed within thesheath).

FIG. 6 is a schematic illustration of a feeding tube carrier inaccordance with one embodiment of the present invention.

FIG. 7 is a schematic illustration of a distal portion of a sheath andtrack showing a carrier advanced to a distal position on the track, andwith an indicator tab extending through a slot in an endcap to beviewable by an endoscope.

FIG. 8 is a schematic illustration showing the distal end of anendoscope being advanced through a sheath, with the sheath, track, andcarrier shown in cross-section.

FIG. 9 is a schematic illustration of a distal portion of a sheath,track, and carrier, and illustrating the carrier and a feeding tubeadvanced to a distal position on the track.

FIG. 10 is a schematic illustration of a feeding tube having a featurefor providing sliding engagement with a track.

FIG. 11 is a schematic illustration of the proximal portion of thefeature shown in FIG. 10.

FIG. 12 is a schematic illustration of a port for use in maintaining thefeeding tube in a desired position in the gastrointestinal tract afterthe feeding tube is positioned and the track has been withdrawn from theGI tract.

FIG. 13 is a schematic side view illustration of a distal portion of thefeeding tube shown in FIG. 10, illustrating a distal portion of apassageway (in phantom) through which nutrients may be directed, suchthat the distal portion of the passageway does not have to bend or curveto communicate with a distal feeding port, with the portion of thefeeding tube extending distally of the distal feeding port beinginclined with respect to the passageway, and the figure illustratingweights (in phantom) which may be employed at a distal end of thefeeding tube.

FIG. 14 is a schematic illustration of a distal portion of a memberwhich may be employed to maintain the feeding tube in a desired positionduring removal of the endoscope and the carrier from the patient's GItract.

FIG. 15 is a schematic illustration of the distal end of the member ofFIG. 14 and showing contact surfaces positioned, sized, and/or shapedfor engaging contact surfaces on the proximal end of a rail featureassociated with a feeding tube.

FIG. 16 is a schematic illustration of the distal portion of the memberof FIG. 14 positioned with respect to the proximal end of the railfeature on the feeding tube.

FIG. 17 is a schematic bottom view illustration of adjacent portions ofthe rail feature on the feeding tube and the member of FIG. 14.

FIG. 18 illustrates introducing an endoscope in a medical device (whichmedical device can include a handle, sheath, endcap, and track) into theGI tract of a patient, such that the endcap and the distal end of thetrack are positioned in the small intestine (such as in the jejunum).

FIG. 19 illustrates advancing a carrier and a feeding tube together onthe track after the endoscope and track have been positioned as shown inFIG. 18, so that the distal end of the feeding tube is positioned in thejejunum.

FIG. 20 illustrates feeding a member distally to a position behind thefeeding tube to hold the feeding tube in place in the GI tract while theendoscope and medical device (which medical device can include a handle,sheath, endcap, and track) are removed in a proximal direction from thepatient.

FIG. 21 illustrates the feeding tube positioned to extend from outsidethe mouth to the small intestine.

FIG. 22 illustrates providing a transfer tube through the nose.

FIG. 23 illustrates associating an end of the transfer tube with theproximal end of the feeding tube.

FIG. 24 illustrates the proximal end of the feeding tube pulled throughthe throat and the nasal cavity (such as with the transfer tube of FIG.23) such that the proximal end of the feeding tube extends from thepatient's nose (from a nostril).

FIG. 25 illustrates positioning an endoscope within a medical device(which medical device can include a handle, sheath, endcap, and track)into the GI tract such that the endcap and the distal end of the trackare disposed in the stomach, such as for use in a PEG tube feedingmethod, and FIG. 25 illustrating a cannula/needle for providing apercutaneous incision through the abdominal wall can be transilluminatedwith a light source associated with the endoscope.

FIG. 26 illustrates removing the needle from the cannula and introducinga looped guidewire through the cannula, and illustrating the distal endof the endoscope, endcap, sheath, and track passing through the loop ofthe looped guidewire.

FIG. 27 advancing a PEG tube (such as a PEG tube having a lengthsubstantially less than the length of the track) on the track, with thePEG tube disposed on the track such that a first end of the PEG tube tobe positioned inside the body is advanced ahead of a second end of thePEG to be positioned through the percutaneous incision, and showing thefirst end of the PEG tube being advanced off of the track.

FIG. 28 illustrates the second end of the PEG tube advanced off of therail and grasping a length of suture extending from the second end ofthe PEG tube with the looped guidewire.

FIG. 29 illustrates pulling the suture loop and the second end of thePEG tube through the percutaneous incision and seating a bumper memberat the first end of the PEG tube against the inside surface of thegastric wall, with the endoscope positioned to provide viewing of theseating.

FIG. 30 illustrates the medical device and endoscope removed from the GItract and the external portion of the PEG tube adapted for introducingnutrients through the abodiminal wall.

FIG. 31 illustrates positioning an endoscope (such as a gastroscope)disposed in a medical device (which medical device can include a handle,sheath, endcap, and track) into the GI tract such that the endcap, thedistal end of the gastroscope, and the distal end of the track aredisposed in the stomach, such as for use in a JET-PEG tube feedingmethod, with FIG. 31 also showing the endoscope can be used totransilluminate the abdominal wall, such that a needle/cannula can beused to make and/or pass through a small incision into the stomach.

FIG. 32 illustrates removing the needle and introducing a loopedguidewire through the cannula, after which the medical device (withgastroscope disposed therein) can be advanced through the loopedguidewire, with the distal end of the medical device and the distal endof the gastroscope being advanced into the jejunum (such as past theLigament of Treitz)

FIG. 33 illustrates positioning a feeding tube (such as a feeding tubehaving a length substantially less than the length of the track) andcarrier on the track, and advancing the feeding tube along the trackuntil the distal end of the feeding tube is positioned in the jejunumand can be viewed by the endoscope.

FIG. 34 illustrates retracting the medical device and gastroscopeproximally into the stomach, while holding a member positionedproximally behind the feeding tube to push the feeding tube off thedistal end of the track, and illustrating grasping a length of sutureextending from the feeding tube with the looped guidewire.

FIG. 35 illustrates pulling the suture and an end of the feeding tubethrough the incision through the abodiminal wall, and leaving a distalend of the feeding tube in the jejunum.

FIG. 36 illustrates the external portion of the feeding tube adapted forintroducing nutrients through the abodiminal wall, with the distal endof the feeding tube being positioned in the jejunum.

FIG. 37 illustrates the feeding tube in place with the gastroscope andmedical device removed.

FIG. 38 illustrates an endcap loading element which can be used to anendcap on the distal end of an endoscope.

FIG. 38A is a cross-sectional schematic illustration of a flexible prongof the endcap loading element.

FIG. 39 illustrates the endcap loading element disposed on the distalend of the endoscope, and the endoscope disposed in the sheath, with theflexible prongs of the endcap loading element disposed within the sheathand engaging an outer surface of the endoscope, with an O-ringcompressing the flexible prongs and positioned against the proximal faceof the endcap, and with a distal portion of the endcap loading elementextending through the bore of the endcap.

FIG. 40 illustrates a handle sliding proximally on the endcap loadingelement to be positioned against the distal face of the endcap.

FIG. 40A is a schematic illustration showing the proximal face a handleand showing an endcap loading element extending into a central bore inthe handle.

FIG. 41 illustrates a ring which can be attached to a distal portion ofthe endcap loading element.

FIG. 42 illustrates pulling distally on the ring while pushingproximally on the handle, to provide a pushing force on the distal faceof the endcap with the handle, while providing a pulling traction forceon the outer surface of the endoscope with the flexible prongs, suchthat the end cap and the O-ring slide off of the endcap loading elementand onto the distal end of the endoscope.

FIG. 43 illustrates a schematic isometric view of an apparatus thatengages an internal surface of an endoscope and can be used to push anendcap onto an endoscope.

FIG. 44 is cross-sectional, schematic illustration of the apparatus ofFIG. 43.

FIG. 45 is a schematic isometric illustration showing the distal end ofan endoscope, the endcap, and the forward portion of the apparatus ofFIG. 43 with a portion of the apparatus being inserted into a workingchannel of the endoscope.

FIG. 46 is a schematic isometric illustration showing expansion of aportion of the apparatus inserted into the working channel of theendoscope.

FIG. 47 is a schematic isometric illustration showing rearward movementof an actuator of the apparatus of FIG. 43 to push the endcap onto theendoscope in a first direction while pulling the endoscope in theopposite direction.

FIG. 48 is a cross-sectional, schematic illustration of a portion of theapparatus of FIG. 43.

FIG. 49 is a cross-sectional, schematic illustration of a portion of theapparatus of FIG. 43.

DETAILED DESCRIPTION OF THE INVENTION

FIGS. 1 and 2 illustrate a medical apparatus 10 according to oneembodiment of the present invention. In one embodiment, apparatus 10 caninclude a handle 100, a flexible catheter or sheath 200 extending fromhandle 100, a flexible track 300 disposed on the sheath 200, and anendcap 400 disposed at the distal end of sheath 200. Handle 100 andflexible sheath 200 can each be sized to receive an endoscopetherethrough.

Apparatus 10 can also include a carrier 500 which is adapted to slidablyengage track 300, as shown in FIG. 2. Endcap 400 can be sized and shapedto engage the distal end of an endoscope, such as an endoscope 1000 asshown in FIG. 2. Endoscope 1000 can be any commercially availableendoscope, such as a gastroscope or colonoscope having an articulatingdistal section, and including a viewing element 1100 and a workingchannel 1200. Any suitable endoscope, including without limitationgastroscopes and pediatric colonscopes can be used with the presentinvention. Suitable endoscopes for use with the present inventioninclude, without limitation, model PCF100, PCF130L, PCF140L, or PCF160ALendoscopes manufactured by Olympus Corporation of Japan. The handle 100,sheath 200, and endcap 400 can be sized to receive various diameterendoscopes, such as, but not limited to, endoscopes having a diameterfrom about 9 mm to about 14 mm.

To introduce the endoscope 1000 with the apparatus 10 into a patient,the operator may start with a clean dry endoscope. The sheath 200 ispreferably formed of a thin, light weight, drapable polymeric filmmaterial which can be relatively soft and elastically extensible, andwhich has substantially no torsional stiffness and no torsional loadcarrying capability. By “drapable” it is meant that the sheath does notmaintain a circular or other regular cross-sectional shape in theabsence of an internal structure (such as an endoscope) supporting thesheath.

In one embodiment, the sheath 200 can be formed of a material having anelastic modulus of less than about 20 ksi, more particularly less thanabout 15 ksi, still more particularly less than about 10 ksi, and evenmore particularly less than about 7 ksi. The sheath can be formed of amaterial having a yield strength of less than about 500 psi, moreparticularly less than about 300 psi, still more particularly less thanabout 200 psi, and still more particularly less than about 125 psi. Inone embodiment, the sheath can be formed of a material having a yieldstrength of between about 90 psi and about 120 psi. The elastic modulusand yield strength can be determined as an average of five or moremeasurements, and can be determined using ASTM test #D882 (Standard TestMethods for Tensile Properties of Thin Plastic Sheeting) using a gagelength of 4.0 inch, a gage width of 1.0 inch, a test thickness equal tothe thickness of the film (e.g about 0.005 inch), and a test machinespeed of 0.4 in/minute. In one embodiment, the sheath can be formed of afilm have a modulus of less than about 7 ksi, a yield strength of lessthan about 125 psi, and a tensile strength at break (measured accordingto ASTM D 638) of at least about 1 M Pa (mega Pascal), more particularlyat least about 5 Mpa, and still more particularly about 10 Mpa orgreater. The sheath can be formed of a film having a tensile elongation(measured using ASTM D 638) of at least about 200 percent, moreparticularly at least about 500 percent, and still more particularlyabout 800 percent or more. The modulus, yield strength, tensilestrength, and elongation are determined as mean of at least fivemeasurements.

In some embodiments, it can be desirable that the sheath 200 can beinserted over the insertion length of the scope without use of alubricant. In one embodiment, the sheath 200 can have a non-smooth,textured inner surface 210 that prevents the inner surface of theflexible sheath from “sticking” to outer surface of the insertionportion of the endoscope. The textured inner surface can also aid ingripping the endoscope through the sheath 200, such as for example if itis desired to rotate the sheath and endoscope together. The innersurface can be textured and the outer surface can be generally smooth,or both the inner and outer surfaces may be textured. The inner surfaceof the sheath 200 may have the same texture as the outside surface, berelatively more textured than the outer surface, or be relatively lesstextured than the outside surface.

The textured inner surface can be provided with elevated portions,depressed portions, or combinations of elevated and depressed portions.For instance, the inner surface can include randomly spaced bumps orprotrusions, or alternatively, can be provided by raised portions (suchas bumps, ribs or protrusions) that occur at regularly spaced intervals,which intervals may be of generally uniform spacing. The texture of theinner surface can be measured in terms of a roughness averagemeasurement, where “roughness average” or “Ra” is the arithmetic averageof the absolute values of the measured profile height deviations dividedby an evaluation length, as set forth on page 728 of the 27^(st) editionof Machinery's Handbook, 2004, incorporated herein by reference. Theroughness average can be measured using optical interferometry with aZygo NewView 100 3D Imaging Surface Structure Analyzer marketed by ZygoCorporation of Middlefield, Conn. The following measurement parametersand analysis parameters can be used:

Measurement Parameters: Acquisition Mode is “Scan”; Camera Mode is320×240 Normal; Phase Controls (AGC is “ON”; Phase res is “High”; MinMod is 1%; Min Area size is 7; Discon Action is “Filter”; ConnectionOrder is “Location”; Remove Fringes is “Off”; Image Zoom is 1×); ScanControls (Scan length is “Extended”; Extended Scan Length is 11000 microinches; FDA Res is “Low”).

Analysis Parameters: Filter is “Lowpass”; Filter Type is “Average”;Filter Window Size is 13; Filter High Freq. 1/mil; Filter Low Freq.1/mil; Filter Trim is “Off”; Remove is “Plane”; Trim is 0; Remove Spikesis “ON”; Spike Height(xRMS) is 1.25; Data Fill is “ON”; Data Fill Max is25. The measurements can be made with a 5× Michelson Objective Lens, andthe samples can be coated with gold or otherwise coated to provide angenerally opaque surface that reflects light. Gold coating can beapplied with a Hummer 6.2 Sputtering System.

In one embodiment, the inner surface of the sheath 200 can a have aroughness average value Ra of less than about 500 micro inch (0.000500inch), more particularly less than about 400 micro inch, still moreparticularly less than about 250 micro inch, and still more particularlyless than about 150 micro inch. In one embodiment, the roughness averagevalue of the inner surface can be between about 50 and about 500 microinch, more particularly between about 50 and about 250 micro inch, andstill more particularly between about 75 and about 125 micro inch. Theroughness average value is determined as a mean of at least fivemeasurements.

The inner surface of the sheath 200 can have a coefficient of frictionwhich is suitable for gripping the endoscope with the sheath 200, butwhich also allows the endoscope to be positioned within the sheathwithout excessive effort. A suitable inner surface can have acoefficient of static friction and a coefficient of sliding frictionwhich can both be less than about 1.0. In one embodiment, thecoefficient of static friction can be between about 0.3 and about 0.6(more particularly between about 0.4 and 0.5) and the coefficient ofsliding friction can be between about 0.3 and about 0.6 (moreparticularly between about 0.4 and about 0.5) using a friction sledformed of Ultem 1000 material. The coefficient of static friction can bebetween about 0.2 and about 0.5 (more particularly between about 0.3 andabout 0.4) and the coefficient of sliding friction can be between about0.2 and about 0.5 (more particularly between about 0.3 and about 0.4)using a friction test sled formed of 440C stainless steel. Thecoefficient of static and sliding friction can be measured using ASTMtest #D1894 (Standard Test Method for Static and Kinetic Coefficients ofFriction of Plastic Film and Sheeting). The coefficient of friction isdetermined as a mean of at least five measurements.

In one embodiment, the sheath 200 can be formed of a thermoplasticpolyolefin film having a thickness of less than about 0.010 inch, andcan comprise polypropylene, polyethylene, and mixtures thereof. In oneembodiment the sheath can be formed of a film having a thickness ofbetween about 0.004 to 0.006 inch, more particularly about 0.005 inch.One suitable film is available as Basell Softell Q020F made by BasellNev., Hoofdorp, Netherlands, such as can be provided by SpecialtyExtrusion, Inc. of Royersford, Pa.

The handle 100 can be formed of any suitable material, including withoutlimitation relatively rigid biocompatible metals and plastics. Onesuitable material from which handle 100 can be formed is moldedpolypropylene, such as is available as Huntsman 12N25ACS296 fromHuntsman Corp. of Houston Tex.

As shown in FIG. 1, handle 100 can have a generally cylindrical proximalsection 102 having a proximal opening for receiving an endoscope, and anadjacent distally converging conical section 104. The handle 100includes an opening 101 at it's proximal end for receiving an endoscope.The handle's internal channel for receiving the endoscope can include agenerally cylindrical channel section 103 (shown in phantom)corresponding to section 102, and a generally conical channel section105 (shown in phantom) corresponding to section 104. The generallyconical channel section 105 can taper from a relatively larger innerdiameter to a relatively small inner diameter as the channel section 105extends distally. A track support structure 120 is shown extending fromsections 102 and 104 to support a track ramp 130 at an inclined anglewith respect to the longitudinal axis of sections 102 and 104. Trackramp 130 can support the proximal portion of the track 300.

FIGS. 1A and 1B illustrate isometric views of an endoscope 1000 insertedinto handle 100. A hinged latch 140 can be positioned at or adjacent tothe proximal end of track 300. The latch 140 can be hinged to the trackramp 130 or structure 120, such as by a living hinge or a mechanical pintype hinge. The latch is shown in an open position in FIG. 1A and aclosed position in FIG. 1B. The latch, when in the closed position,extends over the track 300 at or adjacent the proximal end of the trackand can assist in preventing components slidably supported on track 300from “unzipping” from track 300 or otherwise being dislodged from track300 during use. In FIG. 1B, a carrier 500 and feeding tube 600 (bothdescribed in more detail below) are shown being advanced by hand in adistal direction along track 300.

An elastically extensible member can be employed to provide a distalbiasing force on the endoscope and a proximal biasing force on thehandle 100. For instance, the handle 100 can include an elastic strap150 (shown in FIGS. 18 and 19). The elastic strap can extend from aportion of the handle 100, such as the track ramp 130 or the structure120, to form a loop that encircles a portion of the endoscope 1000, suchan endoscope accessory channel port. The elastic strap 150 is useful foraccommodating variation in endoscope lengths, assists in maintainingtautness of the sheath, and assists in maintaining engagement of theendoscope in the handle. The elastic strap can be employed to compensatefor length changes due to scope bending, and to provide a reslientbiasing force urging the endoscope distally into the handle and sheath.Alternatively, instead an elastic strap, a relatively inelastic strapcould be used, and a biasing member could be employed in the handle orsheath to maintain the sheath and track from pleating or otherwise“bunching” on the endoscope. For instance, the strap could be generallyinextensible, and the handle could be formed of an elasticallyextensible material or geometry, such that the length of the handlewould be extended when the strap was engaged on relatively longerendoscope.

Endcap 400 can be formed of a thermoplastic elastomer for fitting on thedistal end of the endoscope 1000. The endcap 400 can be formed of amaterial having a durometer of less than about 100, and moreparticularly between about 50 and about 90 (as measured using the Ascale, 0.120 inch test according to ASTM D224). The endcap can bepressed onto (e.g. slightly expanded to fit over) the distal end of theendoscope with the distal end of the endoscope being gripped by theendcap 400. One suitable material from which endcap 400 can be formed ismolded Santoprene brand thermoplastic elastomer. Providing an endcap 400from a material such as a thermoplastic elastomer can be desirable inthat such an endcap 400 can be pressed onto the distal end of theendoscope, as described in more detail below.

Referring to FIGS. 1, 2, and 2A, the endcap 400 can include a generallycylindrical body portion 410, a distal face 412, a proximal face 414,and a central bore opening 420 therethrough for receiving the distal endof the endoscope 1000. The endcap 400 can have internal,circumferentially extending grooves 422 spaced apart along the length ofthe internal surface of central bore opening 420. A track recess 424(FIG. 2A) can provided in the upper half of body portion 410. The recess424 can extend distally from the proximal face 414, and can be sized andshaped to receive the distal end of the track 300. If desired, theproximal edge of the bore opening 420 can be tapered or chamfered toassist in pressing the endcap onto the distal end of the endoscope.

The endcap 400 can also include a slot 430 (FIGS. 2 and 2A) extendingthrough at least a portion of the body portion 410 and opening on thedistal face 412. Slot 430 can extend distally from a surface boundingtrack recess 424, to be disposed with respect to track 300 to be atgenerally the same “o'clock” position as track 300. Slot 430 can besized and shaped to receive a tab or other indicator device, asdescribed below. In one embodiment, the proximal end of slot 430 can begenerally aligned with channel 320 in track 300 (described below), andthe distal end of slot 430 can be inclined radially inwardly as the slot430 extends from recess 424 in the distal direction, such that a tab orother indicator device extending through slot 430 is directed distallyand radially inwardly to be viewable by the optics of the endoscope1000. The Endcap 400 can be joined to the distal end of the sheath 200by any suitable method, such as ultrasonic welding.

Track 300 can be supported by sheath 200, and can extend from handle 100to the endcap 400. FIG. 3 shows track 300 supported on sheath 200 with aportion of the track shown in phantom. FIG. 4 illustrates a top planview of the track 300, and FIG. 5 illustrates a cross-sectional view oftrack 300 supported by sheath 200. In FIG. 5, the sheath 200 is shown incross-section as it would appear if disposed on an endoscope forillustration purposes, with it being understood that, in one embodiment,the wall of the sheath 200 can be generally flaccid and drapable, andlack sufficient stiffness to maintain the shape shown in FIG. 5 withoutthe support of the endoscope or other internal support.

Track 300 can be a generally continuous, unitary piece of material whichextends longitudinally a length sufficient to reach from a point outsidethe patient to a point in or distal to the stomach of the patient, suchas through the pylorus and into the small intestine. Track 300 can beformed of a flexible polymeric material, such as extruded polypropelene.One suitable material from which track 300 can be formed is Huntsman23R2Acs321 available from Huntsman Corp. of Houston Tex. The sheath 200can be joined to the track 300 by any suitable joining method, such asby ultrasonic welding. The distal end of the track 300 can be overmolded onto the end cap 400, or otherwise joined to end cap 400 inrecess 424. The handle 100 can be joined to the proximal end of thesheath 200 and the proximal end of the track 300 by any suitable method,such as by ultrasonic welding.

Track 300 can include a generally C shaped channel body 310 defining aninverted T-shaped channel 320 in cross section. The body 310 can includefloor 312, upstanding side walls 314, and inwardly extending prongs 316.The body 310 can also include a plurality of circumferentially extendingside tabs 330 extending outwardly from body 310. Adjacent tabs 330 oneach side of the track 300 can be spaced apart, such as by thescalloping (shown in FIG. 3 in phantom), or by other spacing methods,such as notching, to maintain the flexibility of the track 300. The tabs330 are shown joined to the inner surface 210 of the sheath 200. Tabs330 can be joined to the inner surface 210 by any suitable means, suchas with adhesive or other bonding methods.

Without being limited by theory, the tabs 330 can be employed tostabilize the track 300 with respect to the endoscope when the endoscopeis positioned in sheath 200. The tabs help to maintain radial alignmentof the axis of symmetry of the track channel 320 with respect to theendoscope 1000. Accordingly, the sheath 200 and the track 300 can berotated circumferentially as a unit about the endoscope 1000 todifferent o'clock positions, and the tabs 330 help to maintain the track300 (and channel 320) in proper radial orientation with respect to theendoscope. The desired radial orientation of channel 320 is illustratedin FIG. 5, with the cross-sectional centerline and axis of symmetry ofchannel 320 being generally aligned with a radial line extending fromthe center of the endoscope.

According to one embodiment of the present invention, the track 300 hasat least one portion which has a greater flexibility than anotherportion of the track. For instance, the track 300 can include a portionhaving a bending flexibility and axial flexibility that is greater thanthe bending flexibility and axial flexibility of another portion of thetrack. Referring to FIG. 3, the track 300 is shown schematically to havethree sections of different flexibility. Section A, which can be thedistal most portion of the track 300, can be the most flexible portionof the track in both bending and axial extension. Section A can beassociated with the distal most portion of the endoscope, such as anarticulating portion of the endoscope. Section B can be relatively lessflexible (more stiff) than Section A. Section C can be the proximalportion of the track 300 and can be relatively less flexible than regionB. In one embodiment, Section A can extend about 10 inches, and SectionB can extend about 26 inches. In one embodiment, the length of the track300 can be at least about 50 inches.

In the embodiment shown in the Figures, Sections A and B are interruptedat intervals along their respective lengths to reduce the bendingstiffness and the axial stiffness of the regions, while Section C can begenerally uninterrupted. The interruptions in Sections A and B areprovided by a series of slits 340. As shown in FIGS. 3 and 4, the slits340 on the two sides of the track body 310 are staggered (longitudinallyoffset) relative to each other such that the slits on one side of thetrack body 310 are not aligned with the slits on the other side of thetrack body 310. In the embodiment shown, each slit 340 on one side ofthe track is positioned halfway between the two adjacent slits on theopposite side of the track. Each of the tabs 330 can be positionedbetween a pair of adjacent slits 340. In one embodiment, the slits 340can have a width (measured parallel to the length of channel 320) ofless than about 0.010 inch, more particularly, less than about 0.005inch. The slits 340 can be formed by any suitable knife or other cuttinginstrument. Without being limited by theory, the width and staggering ofthe slits 340 can provide sufficient flexibility of the track 300, whilepreventing a member slidably disposed in the track from “unzipping” fromthe carrier, or “popping out of” the track, such as by deflection ofprongs 316, at positions where the endoscope is bent (or otherconfiguration where the track is bent or otherwise to take on a curvedconfiguration). The provision of selectively placed interruptions in thetrack permits the track to follow the curvature of the endoscope withoutsignificantly increasing the bending stiffness of the assembly of thesheath 200 and endoscope.

In one embodiment, the slits 340 extend through the full thickness ofthe track (thickness as measured in the vertical direction in FIG. 5).Additionally, the slits can extend from one side of the track to extendacross the full the width of one of the prongs 316, and the slits canextend at least halfway across the floor 312.

In the embodiment shown in FIGS. 3 and 4, each of the slits 340 canextend through the full thickness of the track. Additionally, dependingupon the location of the slits 340 along the length of the track, theslits 340 can extend more than halfway, but not fully across the widthof the track. For instance, the slits 340 extend across the longitudinalcenterline of the track in Section A of FIG. 3. Referring to FIG. 5, thedimension W illustrates the width of a slit extending more than halfway,but not fully across the width of the track. The spacing 342 (FIG. 3)between slits 340 on the same side of the track 3090 can be about 0.120to about 0.130 inch in Section A and about 0.250 inch in Section B.

The staggered arrangement of slits 340 that extend beyond the centerlineof the track can provide the advantage that the track 300 does not havea longitudinally continuous load path for carrying tensile loads orbending loads. Without being limited by theory, the staggeredarrangement of slits 340 can be viewed as providing bending sections(indicated by reference number 344 in FIG. 4) in the track 300. Thebending sections 344 can have a length 346 (FIG. 4) defined by theamount the slits 340 on opposite sides of the track overlap, and thebending sections 344 have a width 348 defined by the longitudinalspacing of one slit from the immediately adjacent slit extending fromthe opposite side of the track. In one embodiment, the length 346 can beabout 0.038 inch to about 0.040 inch in Section A, and the width 348 canbe about 0.0625 inch.

FIG. 6 illustrates carrier 500, and FIG. 7 illustrates carrier 500advanced to distal most position on track 300. Carrier 500 can extendfrom a proximal end 502 to a distal end 504. The length of carrier 500can be a length sufficient to reach from a point outside the patient toa point within, or distal to, the patient's stomach. In one embodiment,the length of carrier 500 can be at least about 100 cm, and moreparticularly at least about 72 inches. The carrier 500 can include abody 520, a generally vertically extending web 530, and a track engagingrail 534. Carrier 500 slidably engages track 300, with rail 534 beingsized and shaped to be slidable within channel 320 of track 300. Carrier500 can be of unitary construction, and can be molded or otherwiseformed of a suitable material. In one embodiment, carrier 500 is formedof a relatively low friction materials, such as extruded PTFE (Teflon).

FIG. 8 provides a cross-sectional illustration of carrier 500 supportedon track 300, with the distal end of endoscope 1000 illustrated beingadvanced through the cross-section to illustrate one position ofcomponents on the endoscope's distal end relative to the position of thetrack 300. As shown in FIG. 8, the web 530 extends generally radiallyinwardly from body 520, to position the rail 534 radially inward of thecarrier body 520. The cross-section of web 530 and rail 534, together,can provide a generally inverted “T” configuration.

The carrier body 520 can include a channel 522. Channel 522 can extendsubstantially the full length of body 520. The channel 522 can bebounded by a channel floor 512 and oppositely facing sidewalls 514. Thebody 520 can also include inwardly extending prongs 516 havingoppositely facing sides 518 which are spaced apart to define the throatof the opening of channel 522.

The distal most portion of the track engaging rail 534 can extenddistally beyond body 520 to provide a flexible indicator tab 536. Tab536 can be sized and shaped to be received by slot 430 in endcap 400. Asthe carrier 500 is advanced distally on track 300, the tab 536 will beviewable by the optics of endoscope 1000 once the carrier 500 has reachits distal most position on track 300. Referring to FIGS. 7 and 8, thetab 536 can be viewed through endoscope optics element 1100 as tab 536is advanced distally and radially inwardly from the distal end of slot430.

In one embodiment, the carrier 500 has at least one portion which has agreater flexibility than another portion of the carrier For instance,the carrier 500 can include a body 520 having a distal portion 520Ahaving a bending flexibility and axial flexibility that is greater thana more proximal body portion 520B of the carrier. Referring to FIG. 6,the carrier is shown schematically to have two sections of differentflexibility. Carrier section 520A can be the distal most portion of thecarrier, and can be the most flexible portion of the carrier in bothbending and axial extension. Section 520A can have a length of at leastabout 2 inches. In one embodiment, the length of Section 520A is betweenabout 4 inches and about 10 inches, and more particularly, the length ofsection 520A can be between about 6 and about 8 inches.

In the embodiment shown in the Figures, body section 520A is showninterrupted at intervals along its length to reduce the bendingstiffness and the axial stiffness of the distal portion of the body 520.The interruptions can be provided by a series of slits 540. As shown inFIGS. 6 and 7, the slits 540 on the two sides of the carrier body 520are staggered (longitudinally offset) relative to each other such thatthe slits on one side of the body 520 are not aligned with the slits onthe other side of the body 520. In the embodiment shown, each slit 540on one side of the carrier body is positioned axially halfway betweenthe two adjacent slits on the opposite side of the track. Adjacentprongs 516 can be separated by slits 540.

Without being limited by theory, the flexible tab 536 and the slits 540can help to prevent the distal portion of the carrier 500 from “jumpingout” of or “unzipping from” the track. For instance, flexible tab 536can “bridge” the space between the slits 340 in track 300 to helpprevent the carrier from being discharged radially from the track 300.Without being limited by theory, the width and staggering of the slits540 can also provide sufficient flexibility of the carrier 500, whilepreventing a member slidably disposed in the carrier from “unzipping”from the carrier, or “popping out of” the carrier.

In one embodiment, the slits 540 can extend through the full thicknessof the track (thickness as measured in the vertical direction in FIG.8). Additionally, the slits can extend from one side of the track toextend across the full the width of one of the prongs 516, and the slitscan continue through at least a portion of the floor 512. Each of theslits 540 can extend through the full thickness of the track body 520,and each of the slits 540 can extend more than halfway, but not fullyacross the width of the track. The spacing 542 (FIG. 6) between slits540 on the same side of the carrier body can be between about 0.1 inchand about 0.6 inch in carrier body portion 520A. The staggeredarrangement of slits 540 provide the advantage that the carrier bodyportion 520A does not have a longitudinally continuous load path forcarrying tensile loads or bending loads.

FIGS. 9-13 illustrate a feeding tube 600 which can be used with thetrack 300 and the carrier 500. Feeding tube 600 can have a proximal end602 and a distal end 604. Feeding tube 600 can include a feeding tubebody 610 having a nutrient passageway 620 for passing nutrients, and afeature 660 adapted to provide releasable engagement of the feeding tube600 with another member. For instance, the feature 660 can include arail for providing sliding engagement of the feeding tube with a trackor the carrier 500.

The passageway 620 can extend from proximal end 602 to an exit port 622through which nutrients exit the passageway 620 and enter the patient'sGI tract. The portion of the feeding tube 600 extending distally of exitport 622 can be inclined with respect to the longitudinal axis of thepassageway 620, as shown in FIGS. 10 and 13, and with exit port 622having a generally tapered, elongated configuration. Accordingly, asshown in FIGS. 10 and 13, the passageway 620 can be generally parallelwith respect to the longitudinal axis of the feeding tube 610, and thepassageway 620 does not bend or curve to communicate with the exit port622, except to the extend the tube 610 itself is bent. Having thepassageway 620 run substantially straight to exit port 622 and thedistal tip portion of the feeding tube inclined with respect to thepassageway 620 can provide the advantage that passageway 620 can beeasily cleaned, such as by running a wire from the proximal entrance ofthe feeding tube through the passageway 620 and out through exit port622.

Referring to FIG. 12, feeding tube 600 can include one or more suctionports positioned either proximally or distally of exit port 622. Suctionports can be used to hold the distal end of the tube 600 in a desiredposition within the body once the tube 600 is placed, and preventmigration of the feeding tube 600 during feeding. In FIG. 10, a suctionport 680 is shown positioned distally of exit port 622. Suction port 680can include a plurality of radially inwardly extending tabs 682 whichcan engage and hold tissue when tissue is drawn into the tube 600 byvacuum applied to suction port 680. The tabs 682 can be formed bycutting or slitting the outer wall of tube body 610 to create the tabs682, or tabs 682 can be provided in a separate member, such as ametallic or non metallic insert that is formed to include tabs 682, andwhich is positioned in an aperture in the wall of tube body 610. Vacuumcan be communicated to suction port 680 through a vacuum passageway (notshown) which communicates with, or extends separately of, nutrientpassageway 620. Weights 690 can be disposed in the distal end of tube600 to assist in maneuvering and positioning the feeding tube 600.

The feature 660 can extend along at least a portion of the length offeeding tube 600. In FIG. 10, the feature 660 is shown extending alongsome, but not all of the length of the feeding tube 600. Feature 660 canextend from a proximal end 662 of feature 660 to a distal end 664. Theproximal end 662 of the feature 660 can be spaced from the proximal endof the feeding tube 600 by a distance L, so that the portion of thefeeding tube 600 which extends through the throat and/or nose of thepatient when the feeding tube 600 is in place does not irritate thepatient or interfere with feeding. The distance L can be between aboutsix inches and about 24 inches, and in one embodiment is about 18inches.

The feature 660 can be integrally formed with the tube body 610 (such asby molding or extruding). Alternatively, the feature 660 could bemanufactured separately from tube body 610, and subsequently attached tobody 610, such as by use of any suitable bonding or joining method.Feature 660 can be sized and shaped to permit the feeding tube 600 toreleasably engage another member, such as track 300 or carrier 500, suchas by sliding engagement. In FIG. 9, the feeding tube 600 is shownslidably supported on carrier 500. The feature 660 can comprise a rail666 and a web 668, with web 668 extending generally radially from tubebody 610 to support rail 666 in spaced relationship from tube body 610.In FIG. 9, rail 666 is positioned in channel 522, with web 668 extendingthrough the throat of channel 522. Without being limited by theory, itis believed that slidably supporting the feeding tube 600 on carrier 500while slidably supporting the carrier 500 on track 300 is advantageousin providing for smooth, relatively low friction positioning of feedingtube 600 within the patient. Alternatively, feeding tube 600 could beslidably supported directly on track 300, such as by having rail 666engage track 300 directly. For example, if desired, the track 300 couldbe coated with Teflon or any other suitable low friction coating.

FIG. 11 illustrates the proximal end 662 of feature 660. A taperedsurface 672 can be provided at proximal end 662 to prevent tissue frombeing caught or pinched as web 668 and rail 666 slide with respect tothe channel 522 of carrier 500. The proximal end of rail 666 can beformed, such as by tapering, to provide contact surfaces 674 disposed atthe proximal end of rail 666, on either side of web 668. Contactsurfaces 674 can be angled with respect to the longitudinal axis of thefeeding tube 600 (in FIG. 11 the surfaces 674 are inclined to extendoutwardly as they extend distally). The contact surfaces 672 provide asurface at which a force can be provided to feature 660 in order to pushthe feeding tube 600 distally along carrier 500. The orientation of thecontact surfaces 672 can be selected with respect to the longitudinalaxis of the feeding tube 600 such that the force applied to push thetube 600 distally on carrier 500 does not tend to push the feature 660out of the channel 522 in carrier 500.

If desired, the carrier 500 and the feeding tube 600 with feature 660can be packaged together. For instance, the carrier 500 and feeding tube600 could be packaged together, with the feeding tube 600 pre-assembledon the carrier 500 such as by sliding engagement of the tube with thecarrier 500. The assembly of the carrier 500 with the tube 600 supportedalong the length of the carrier can be unpackaged (such as from sterilepackaging) at the point of use, and the assembly of the carrier 500 andtube 600 could be advanced along the track 300.

FIG. 14 is a side view illustration of the distal portion of a feedingtube positioning member 700. Member 700 can be used to push the feedingtube distally along the carrier 500 and/or to maintain the feed tube 600in a desired position in the GI tract as the endoscope is withdrawn fromthe patient. FIG. 15 is an enlarged illustration of the distal end ofthe member 700. FIG. 16 illustrates the member 700 positioned tomaintain the feeding tube 600 in a desired position, and FIG. 17 is anenlarged bottom view of the engagement of the distal end of member 700with proximal end 662 of feature 660 on feeding tube 600. In oneembodiment, the length of member 700 can be at least about 36 inches sothat the member 700 can extend from a point outside the patient toengage the contact surface 672 on the feeding tube 600 when the feedingtube is positioned in a desired location in the patient's GI tract.

Referring to FIGS. 14 and 15, the member 700 can have a structuresimilar to that of the carrier 500. Alternatively, member 700 can have adifferent cross-sectional shape. The member 700 can include a bodyportion 710, which may include slits 740 to provide flexibility. Themember 700 can include a rail 766 and a web 768, with web 768 extendingfrom body 710 to support rail 766 in spaced relationship body 710. Rail766 can be sized and shaped for sliding movement within channel 520 ofcarrier 500.

As shown in FIG. 15, the distal end 702 of member 700 can have a taperedsurface 772 on body portion 710. The distal end of rail 766 can beformed to have a V shaped notch with two surfaces 774 being provided toengage surfaces 674 on the feeding tube 600. The surfaces 774 arepositioned distally of the surface 772 and are sized and shaped tocontact surfaces 674 on feeding tube 600 such that the rail 766 ofmember 700 can be employed to exert a force on rail 666 of the feedingtube which force is generally parallel to the rail 766 and rail 666.Such surfaces can provide a desired longitudinally directed forcewithout a radial force component, or other force component that mighturge feeding tube 600 out of the carrier 500 in an undesired manner.

The endoscope with sheath 200 and track 300 can be positioned in apatient such that the distal end of the endoscope is positioned at adesired position within the GI tract for feeding tube placement. Thefeeding tube 600 can be positioned on carrier 500 by sliding the feedingtube onto carrier 500 outside of the patient (or the feeding tube 600and carrier 500 can be provided in a pre-packaged assembly), and thecarrier 500 and feeding tube 600 can then be advanced together alongtrack 300 to a desired position in the GI tract, such as with the distalportion of the feeding tube positioned in the stomach or smallintestine. The tab 536 on carrier 500 can be viewed through theendoscope optics once the tab 536 extends through the endcap 400,thereby providing visual indication that the carrier and feeding tubehave reached the desired position. Alternatively, the carrier 500 couldbe advanced to along the track 300, and then the feeding tube 600 couldbe advanced along the carrier 500 to the desire position.

Once distal end of the feeding tube 600 has been advanced to a desiredposition in the body, the endoscope, sheath 200, track 200, and carrier500 can be removed from the GI tract leaving the feeding tube in place.In order to prevent the feeding tube from “backing out” or otherwisemoving in a proximal direction as the other components are removed fromthe body, feeding tube positioning member 700 can be employed tomaintain the position of the feeding tube during removal of the othercomponents. After positioning of the feeding tube 600 (and prior toremoval of the endoscope, sheath 200, track 300, and carrier 500), themember 700 can be inserted in carrier 500 (with rail 766 positioned inchannel 520 of carrier 500 so that member 700 slidably engages carrier500) and the member 700 can be advanced distally along the carrier 500until the distal end of the member 700 is adjacent the proximal end 662of the rail 666 on feeding tube 600. As the endoscope, sheath 200, track300, and carrier 500 are withdrawn in a proximal direction from thepatient's body, the member 700 can be held in place (such as by thehands of the physician, a physicians assistance, or a fixture) tomaintain the member 700 stationary with respect to the endoscope,sheath, track, and carrier, and exerting a force on the feeding tuberail 666 at the interface of surfaces 774 and surfaces 674, thereby“blocking” the feeding tube 600 from backing up proximal duringwithdrawal of the endoscope and other components.

FIGS. 18-24 illustrate steps which may be employed in a method forpositioning a feeding tube according to one embodiment of the presentinvention. The endoscope can be inserted into the sheath 200, with theendcap 400 positioned at a distal end of the sheath 200, the handle 100positioned at a proximal end of the sheath 200, and with the track 300extending along the sheath 200 from the endcap 400 to the handle 100. Asused herein after, the term “sheath assembly” shall refer to theassembly of the sheath 200, handle 100, endcap 400, and track 300. Afterinserting the endoscope into the sheath assembly outside of the patient,the sheath assembly and endoscope can be inserted into a naturallyoccurring body opening, such as the mouth, and the sheath assembly withendoscope can be advanced so that the distal end of the endoscope andthe endcap 400 are positioned at a desired location, such as the smallintestine. FIG. 18 illustrates the sheath assembly positioned in the GItract of a patient, with the track 300 extending from a position outsidethe body to a position in the small intestine.

The feeding tube 600 can be positioned on the carrier 500 outside of thepatients body, such as by sliding the feeding tube rail 666 in thechannel 520 of the carrier 500 until the feeding tube 600 is positionedalong the length of the carrier 500, with the distal end of the feedingtube positioned at or adjacent to the distal end of the carrier 500.Referring to FIG. 19, the carrier 500 and feeding tube 600 can then beadvanced (such as by hand in the direction of arrow 2) together alongtrack 300, with the carrier and feeding tube being advanced from aposition outside the patient to a position where the distal end of thefeeding tube is positioned at a desired location (the small intestine inFIG. 19). The length of feeding tube 600 can, in one embodiment, be atleast about 140 cm long, and the distal end of the feeding tube can bepositioned between about 130 to about 140 cm from the patients incisors.By way of non-limiting example, a 140 cm length 10 Fr Dobb-Hoff-typefeeding tube (available from Viasys Healthcare, Inc.) can be modified tohave the rail 666 feature, such as by bonding or otherwise attaching aweb and rail to the tube. A pediatric colonoscope, such as an Olympusmodel PCF100 pediatric colonoscope can be employed with the sheathassembly.

Referring to FIG. 20, once, the feeding tube 600 is in the desiredposition, the member 700 can be advanced distally (such as by hand inthe direction of arrow 4) along the track 300 until the distal end 702of the member 700 makes contact with the proximal end of the rail 666 offeeding tube 600. Then, as the member 700 is held stationary withrespect to the patient's body and to the sheath assembly, the sheathassembly (with endoscope), and the carrier 500 can be withdrawnproximally from the body, in the direction indicated by arrow 6. Anytendency of the feeding tube 600 to move proximally during withdrawal ofthe endoscope, sheath assembly, and carrier 500 is prevented by abuttingengagement of the surfaces 774 on member 700 with the surfaces 674 onthe feeding tube rail 666. Accordingly, the feeding tube 600 ismaintained in position by member 700 as the endoscope, the sheathassembly, and the carrier 500 are withdrawn from the body.

FIG. 21 illustrates the feeding tube in place in the patient's GI tractafter removal of the endoscope, sheath assembly, and carrier 500. InFIG. 21, the feeding tube 600 extends from the feeding tube proximal end602 (positioned outside the patient's body) to the feeding tube distalend 604 (positioned in the small intestine), with the feeding tube 600extending through the mouth, the esophagus, the stomach, and into thesmall intestine.

If desired, the feeding tube can be used in the position shown in FIG.21. However, it may generally be desirable to have the proximal end ofthe feeding tube extending from the nose. FIG. 22 illustrates use of atransfer tube 12 which may be inserted to extend from the mouth and thenose. The end of the transfer tube extending from the mouth can becoupled to the proximal end 602 of the feeding tube, as shown in FIG.23. The end of the transfer tube 12 extending from the nose can then bepulled so that the proximal end 602 of the feeding tube is redirected toextend from the nose, as shown in FIG. 24. A suitable fitting 14 canthen be attached to the proximal end 602 of the feeding tube, as shownin FIG. 24.

FIGS. 25-30 illustrate an alternative method for positioning a feedingtube within a patient for providing feeding access through an incisionin the patient's abdominal wall. FIGS. 25-30 illustrate a method ofplacing a feeding tube in the stomach as an alternative to standard PEGprocedures. Referring first to FIG. 25, the endoscope disposed withinthe sheath assembly comprising the handle 100, sheath 200 and endcap 400can be advanced through the mouth to position the distal end of theendoscope and the endcap 400 within the stomach of the patient. A lightsource (such as a light source associated with the distal end of theendoscope) can be employed from within the stomach to transilluminatethe abdominal wall, so that the position of the endoscope within thestomach can be observed from outside the patient. A small, percutaneousincision can be made through the abdominal wall, and a needle 22/cannula24, such as a 14 gauge needle 22/cannula 24 can be inserted through theincision so that the distal tip of the needle and the distal end of thecannula can be positioned within the stomach.

Referring to FIG. 26, the needle 22 can be withdrawn, leaving thecannula 24 to provide an access channel extending from inside thestomach to a point outside the patient. A looped guide wire 32 can bepassed through the cannula, and the endoscope and sheath assembly can bedirected to extend through the loop provided by the guide wire 32.

Referring to FIG. 27, a relatively short feeding tube 800 isillustrated, the feeding tube having a length substantially less thanthe length of the track 300. Feeding tube 800 in this embodiment canhave a length of less than about 3 feet. The feeding tube 800 can be acommercially available PEG type feeding tube modified to have a feature,such as a rail (not shown), for permitting the feeding tube 800 toslidably engage the track 300 and/or carrier 500. For instance, thefeeding tube 800 can be formed by attaching a web and rail to acommercially available PEG feeding tube, such as by bonding or otherwiseattaching the web and rail to the feeding tube (alternatively, thefeeding tube 800 could be formed by extruding or otherwise forming afeeding tube to have an integral web and rail feature). One suitablecommercially available PEG type feeding tube from which feeding tube 800can be constructed is available from Viasys Healthcare of Wheeling, Ill.as marketed in a Corflo-Max brand PEG kit for use with a Push Techniqueor Pull Technique. The feeding tube 800 can include a sealing bumper orbolster 810 and a tapered dilating tip 820.

Referring to FIG. 27, with the sheath assembly extending through theloop provided by guide wire 32, the feeding tube 800 can advanceddistally along the sheath assembly and into the stomach. The feedingtube 800 can be positioned on track 300 and advanced distally alongtrack 300 to the stomach by using member 700 as a pushing element.Alternatively, the feeding tube can be disposed on carrier 500, and thecarrier 500 with feeding tube 800 can be advanced along track 300 to thestomach.

Referring to FIG. 28, the feeding tube 800 can be pushed off the distalend of the sheath assembly using a member, such as a member 700described above. As the feeding tube 800 is pushed off the sheathassembly, a suture 830 (or other suitable flexible wire or tether) thatextends from the tip 820 can be grasped with the guidewire 32 so thatthe suture 830 can be pulled through cannula 24.

Referring to FIG. 29, the suture 830 can be pulled (such as with forcepsor a hemostat) so that tip 820 extends through the percutaneous incisionthrough the abdominal wall and such that the sealing bumper 810 ispositioned against the inside surface of gastric wall (inside surface ofthe stomach).

Referring to FIG. 30, the sheath assembly can be removed from thepatient, and an external seal 840 can be advanced over the feeding tube800 to fit against the patients skin adjacent the incision. The feedingtube 800 can be cut to sever the tip 820 from the feeding tube, and afitting 850 can be positioned on the end of the feeding tube external ofthe patient. In the procedure illustrated in FIGS. 25-30, a feeding tubeis introduced into the patient through a naturally occurring orifice andpushed distally along an endoscope after the endoscope has beenpositioned in the stomach. The feeding tube is then pulled through anincision to provide a feeding access channel that extends through anincision to the patient's GI tract.

FIGS. 31-37 illustrate steps which can be employed in a method forpositioning a feeding tube according to another embodiment of thepresent invention. FIGS. 25-30 illustrate a method of placing a feedingtube in the small intestine as an alternative to standard JET-PEG typeprocedures.

Referring first to FIG. 31, the endoscope 1000 disposed within thesheath assembly comprising the handle 100, sheath 200 and endcap 400 canbe advanced through the mouth to position the distal end of theendoscope and the endcap 400 within the stomach of the patient. A lightsource (such as a light source associated with the distal end of theendoscope) can be employed from within the stomach to transilluminatethe abdominal wall, so that the position of the endoscope within thestomach can be observed from outside the patient. A small, percutaneousincision can be made through the abdominal wall, and a needle 22/cannula24, such as a 14 gauge needle 22/cannula 24 can be inserted through theincision so that the distal tip of the needle and the distal end of thecannula can be positioned within the stomach.

Referring to FIG. 32, the needle 22 can be withdrawn, leaving thecannula 24 to provide an access channel extending from inside thestomach to a point outside the patient. A looped guide wire 32 can bepassed through the cannula, and the endoscope and sheath assembly can bedirected to extend through the loop provided by the guide wire 32. Theendoscope and sheath assembly can be advanced distally from the stomachinto the small intestine, as shown in FIG. 32.

Referring to FIG. 33, a feeding tube 900 can be advanced along thelength of the sheath assembly such that the feeding tube 900 passesthrough the loop provided by guidewire 32. The feeding tube 900 shown inFIG. 3 can include a distal portion 904 having a construction like thatof the feeding tube 600 described above, and a proximal portion 906having a construction similar to that of the feeding tube 800 describedabove. The proximal portion 906 can include a tapered dilating tip 920and a bumper or bolster 910. The proximal portion 906 can be constructedusing a PEG feeding tube of the type provided in Corflo-Max brand PEGKits for Pull Technique or Push Technique, which kits are available fromViasys Healthcare of Wheeling, Ill.

The opening through which food is delivered to the GI tract can belocated in the distal portion 904. The feeding tube 900 can include afeature, such as a rail (such as the type shown in FIGS. 10, 11, and 13)on one or both of the portions 904 and 906 such that feeding tube canslidably engage the track 300 and/or the carrier 500. In one embodiment,the feeding tube 900 is positioned on the carrier 500 outside of thepatient's body, and the feeding tube 900 and carrier are advancedtogether along track 300. The positioning member 700 can be advancedalong carrier 500 behind feeding tube 900. If desired, the positioningmember 700 can include a grasping clip 715 which can clip onto orotherwise be fastened to member 700 to assist in grasping and pushingthe member 700 along carrier 500.

Referring to FIG. 34, with the positioning member 700 held in position,the endoscope and sheath assembly can be retracted proximally from thestomach, such that the feeding tube 900 is pushed off the end of thesheath assembly by positioning member 700 as the endoscope and sheathassembly are retracted. A length of suture 930 extending from the tip920 can be grasped using the looped guide wire 32.

Referring to FIG. 35, the suture 930 and tip 920 can be pulled throughthe incision until bumper 910 is positioned against the inside surfaceof the stomach, with the portion 904 of the feeding tube including theport through which food is provided being positioned in the smallintestine (such as the jejunum). Referring to FIG. 36 an external seal940 can be advanced over the feeding tube 900 to fit against thepatients skin adjacent the incision. The feeding tube 900 can be cut tosever the tip 920 from the feeding tube, along with any unneeded lengthof the tube, and a fitting 950 can be positioned on the end of thefeeding tube external of the patient. In FIG. 37, the endoscope andsheath assembly are shown removed from the patient's body, and thefeeding tube 900 is shown positioned with the distal portion 904disposed in the small intestine, and with the feeding tube 900 extendingfrom the small intestine through the stomach to pass through an incisionthrough the stomach and through the patient's abdominal wall and skin.

In the procedure illustrated in FIGS. 31-37, a feeding tube isintroduced into the patient through a naturally occurring orifice andpushed distally along an endoscope after the endoscope has beenpositioned in the stomach. The feeding tube is then pulled through anincision to provide a feeding access channel that extends through apercutaneous incision into the patient's GI tract (eg. small intestine).

FIGS. 38-42 illustrate a method for positioning and endcap 400 (such asan elastomeric endcap 400) and sheath 200 on an endoscope 1000 prior toinserting the endoscope on the sheath assembly into the patient. In someapplications, it may be difficult to manually load an endoscope into asheath having an endcap, such as by gripping the components by hand. Forinstance, it may be difficult to grip the endoscope through the sheathand apply the appropriate force to urge the endcap to fit over thedistal end of the endoscope. Additionally, it may be desirable tomaintain a certain angular “o'clock” orientation of the endcap withrespect to the endoscope. In the course of applying the force to urgethe endcap onto the endoscope, the desired o'clock orientation may beinadvertently lost, requiring re-installation. The method and componentsillustrated in FIGS. 38-42 can be employed to assist in properinstallation of an endcap (and associated sheath and track) onto anendoscope. Additionally, the method and components can be employed toinstall an endcap on an endoscope even if no sheath and or track isemployed.

Referring to FIG. 38, an endcap loading element is shown in the form ofa nose cone 2100. The nose cone 2100 can be disposable, and can beformed of a lightweight material, such as a polymeric material. The nosecone 2100 can include a body portion 2110 and a plurality of flexibleprongs 2120 (six prongs shown in FIG. 38). The distal end 2102 of thebody portion 2110 can be rounded or tapered. The body portion 2110 caninclude a through hole 2112 which extends through the width of bodyportion 2110 in a direction transverse to the longitudinal axis of thebody portion 2110. The body portion 2110 and the prongs 2120 can besized and shaped to pass through the central bore opening 420 of endcap400.

The body portion 2110 can include a plurality of radial splines 2114which extend along the length of body portion 2110. Each spline 2114 canbe associated with a rounded or sloped prong shoulder 2118. Each prongshoulder 2118 can be associated with a flexible prong 2120. Eachflexible prong 2120 can extend proximally from a prong shoulder 2118 toa proximal prong end 2122. Each rounded prong shoulder 2118 canextending radially outward from its associated spline 2114 on the bodyportion 2110 to the flexible prong 2120 associated with that prongshoulder.

The radially outward surfaces of the splines 2114 can define a firstdiameter of the nose cone 2100, and the radially outward surfaces of theprongs 2120 can define a second diameter of the nose cone, with thesecond diameter being greater than the first diameter. The radiallyouter surface of each rounded prong shoulder 2118 can be shaped toprovide a smooth radial transition from each spline to its associatedprong. Accordingly, the rounded prong shoulders 2118, together, providea smooth radial transition from the first diameter to the seconddiameter. The radially inward facing surfaces of the flexible prongs2120 can be spaced apart (either by being formed in that fashion, or dueto an applied force) to receive the distal end of the endoscope 1000.

The splines 2114, rounded prong shoulders 2118, and the prongs 2120 canbe circumferentially spaced apart at generally equal angular intervals(e.g. for six splines, six prong shoulders, and six prongs, eachassociated spline, prong shoulder, flexible prong could be spaced at 60degree intervals about the circumference of the body portion 2110).

Each prong 2120 can have a slot 2124 formed in the outwardly facingsurface, as shown in FIG. 38A and FIG. 40A. Together, the slots 2124 inthe prongs 2120 provide a circumferentially interrupted groove in whichan expandable ring, such as a silicone O-ring or Teflon O-ring 2160 canbe seated. The radial thickness 2123 of the prongs 2120 illustrated inFIG. 38A can be sized to take into account various factors, such as theinner diameter and material of the endcap, the outer diameter of thedistal end of the endoscope 1000, and the number of prongs 2120 on nosecone 2100, such that when prongs 2120 are disposed between the outersurface of the distal end of the endoscope, and the inner surface of theendcap, the radially inner surface of the endcap is spaced from theouter surface of the endoscope. One suitable thickness 2123 when sixprongs 2120 are employed is about 0.032 inch.

Prior to seating the O-ring 2160 in the slots 2124, the distal end ofthe endoscope 1000 can be inserted between the prongs 2120. The O-ring2160 can then be slid over body 2110 of nose cone 2100 and up over therounded prong shoulders 2118. The O-ring can be stretched over theshoulders 2118 and be seated in the slots 2124 in prongs 2120. TheO-ring can thereby provide a radially inward compressive force on theprongs 2120, urging the radially inwardly facing surfaces of the prongs2120 into engagement with the outer surface of the distal end of theendoscope 1000.

With the nose cone 2100 positioned on the distal end of the endoscope1000 the endoscope 1000 is loaded onto the sheath assembly (comprisingthe handle 100, sheath 200, track 300, and endcap 400). The endoscope isloaded onto the sheath assembly such that the body portion 2110 of nosecone 2100 extends distally from the endcap 400, as shown in FIG. 39, andsuch that the proximal face of the endcap 400 abuts against prongshoulders. The O-ring 2160 and two proximal prong ends 2122 are shown inphantom in FIG. 39, as the O-ring and prong ends would be inside thesheath (but can be visible when sheath 200 is made of a substantiallytransparent film material).

Referring now to FIG. 40 and FIG. 40A, a handle 2200 is shown with apair of outwardling extending arms 2204 extending from a central hub2208. The hub 2208 includes a grooved through bore 2210. The throughbore 2210 has grooves sized and shaped to permit the handle 2200 toslide longitudinally along the splines 2114 of body portion 2110 on nosecone 2100. The engagement of the splines 2114 with the grooved bore 2210prevents rotation of the handle 2200 with respect to the nose cone 2100and the endcap 400. While rotation of the handle 2200 with respect tothe nose cone 2100 could be permitted in an alternative embodiment thatdoes not employ splines and grooves, it can be advantageous to preventrotation of the handle 2200 with respect to the nose cone 2100. Forinstance, it may be desirable to load the endcap 400 and track 300 ontothe endoscope in such a way to maintain a desired o'clock orientation ofthe track 300 with respect to features such as optics and/or workingchannels in the distal end of the endoscope. Maintaining the handle 2200rotationally fixed with respect to the nose cone 2100 can aid inavoiding angular misalignment of the track 300 with respect to thedistal end of the endoscope 1000.

FIG. 40A illustrates the nose cone 2100 extending into the bore 2210from the proximal side of the handle 2200. The proximal side of handle2200 can include one or more surfaces for providing a pressing forceagainst distal surface 412 of endcap 400. In FIG. 40A, the handle 2200is shown having multiple generally wedge shaped extensions 2700extending proximally from handle 2200. In FIG. 40A, six extensions 2700are provided, one for each groove in the through bore 2210. Theextensions 2700 can be separated by a distance substantially equal tothe width of the grooves in the through bore 2210. The extensions 2700each have a proximally facing surface 2710. Together, the surfaces 2710can engage the distal surface 412 of endcap 400 as handle 2200 isadvanced proximally along nose cone 2100. Providing separate, spacedapart surfaces 2710 can be beneficial in preventing the material ofendcap 400 from being pinched between the nose cone 2100 and the handle2200 as the handle 2200 provides a pushing force against endcap 400 andprongs 2120 provide a pulling force on the distal end of the endoscope.

Referring to FIG. 41, a pull ring 2300 is shown attached to a distal endof the nose cone 2100, such as with a pin 2308 which extends through apull ring collar 2304 and into through bore 2112 in nose cone 2100. Thecombination of the pull ring 2300 mounted on the distal end of the nosecone 2100 and the handle 2200 slidably supported on the nose cone 2100via the spline and groove arrangement permits a user to provide a distalpulling (tensile) force on the endoscope 1000 through the endcap 400 viathe nose cone 2100, while at the same time exerting a proximal pushing(compressive) force on the distal face of the endcap 400 via thesurfaces 2710 of handle 2200.

Referring to FIG. 42, the application of such forces is illustratedschematically by arrows 2250 and 2350. By pulling on the pull ring 2300in the direction indicated by arrow 2350 while pushing on the handle2200 in the direction indicated by arrows 2250, the endcap 400 is pushedonto the distal end of the endoscope 1000 and the O-ring is forced offthe prongs 2120, such that the prongs 2120 can disengage from the distalend of the endoscope 1000 and be pulled through the through bore 420 ofthe endcap 400. O-ring 2160 can remain positioned about the endoscopeproximal of the endcap 400.

In the installation embodiment shown in FIGS. 38-42, a distal pullingforce is applied to the outside surface of the endoscope 1000 withflexible prongs 2120 as a proximal pushing force is provided by handle2200 against the distal face of the endcap 400. FIGS. 43-47 illustratean alternative apparatus and method for use in positioning an endcap onan endoscope, which can be employed to provide a pulling force at aninternal surface of an endoscope, such as an internal surface of aworking channel of an endoscope, as a pushing force is applied to theendcap. The sheath and track are omitted from the Figures for clarity,with it being understood that the apparatus and method illustrated inFIGS. 43-47 can be used to position an endcap on the distal end of anendoscope, including in applications where a sheath and/or track is notemployed.

FIG. 43 is a schematic isometric view of the loading apparatus 3000, andFIG. 44 is a partial cross-sectional illustration of the apparatus 3000.In FIGS. 43 and 44, the endcap 400 is shown for illustration purposes,with it being understood that the endcap 400 is not part of theapparatus 3000. FIGS. 45, 46, and 47 illustrate steps in employing theapparatus 3000 to load an endcap 400 on and endoscope, with theendoscope and endcap being illustrated to be generally transparent forpurposes of illustration and clarity (though endcap 400 and endoscopecould be formed of generally transparent materials if desired).

Apparatus 3000 includes a body section 3100, a rotation section 3200,and translating section 3300, and a ring 3400. As shown in FIGS. 45 and46, the apparatus 3000 can include one or more expandable members, suchas resilient cylinders 3500, which can engage an internal surface of theendoscope, such as by being positioned within a working channel of theendoscope. Cylinders 3500 can be formed of any suitable material, suchas rubber or synthetic elastomeric materials, which expands radiallywhen compressed axially. Alternatively, other types of expandablemembers could be employed, such as members which expand by inflation.

Referring to FIG. 46, the cylinders 3500 can be expanded to engage theinside surface of the working channel. Expansion of the rubber cylinderscan be provided, in part, in connection with the rotation of rotationsection 3200, as described more fully below.

Referring to FIG. 47, with the cylinders 3500 expanded within theworking channel of the endoscope to compressively engage the radiallyinner surface of the working channel, the translating section 3300 canbe drawn distally relative to body section 3100 (as indicated by arrows3302 in FIG. 47). As shown in the Figures, body section 3100 can includea recess 3120 having a proximally facing surface 3122 for engaging thedistal surface 412 of endcap 400. As translating section 3300 is drawndistally relative to body section 3100, the cylinders 3500 can beretracted distally relative to body section 3100. Accordingly, thecombination of the pulling force provided on the endoscope by thecylinders 3500 being pulled distally while engaging the inside surfaceof the working channel, and the complementary reactive pushing forceexerted on the distal surface 412 of endcap 400 by surface 3122, servesto press the endcap 400 onto the distal end of the endoscope.Accordingly, the apparatus 3000 can be used to install the endcap 400 onthe distal end of the endoscope without holding or otherwise contactingthe exterior surface of the endoscope or the sheath (if a sheath isemployed).

The components and operation of the apparatus 3000 will now be describedin more detail with reference to FIGS. 43-47, as well as cross-sectionalillustrations 48 and 49. Body portion 3100 can include an outer surfaceprovided by two body halves 3106 and 3108. Body halves can be joinedtogether in any suitable manner, such as with screw type fasteners,rivets, with adhesive, and the like.

The translating section 3300 can be disposed at least partially withinthe body portion 3100, and can include a hub 3316 and outwardlyextending ring grips 3318. The ring grips 3318 can extend outwardly fromhub 3316 through slots provided between body portion shell halves 3106and 3108.

Referring to FIG. 44 and FIG. 48, rotating section 3200 can be supportedat an end of body portion 3100 such that rotating section 3200 isrotatable with respect to body portion 3100 and such that rotatingsection is rotatable with respect to translating section 3100. As shownin FIG. 48, rotating section 3200 can have end 3202 received within arecess 3105 provided by body halves 3106 and 3108. End 3202 can includea ring 3204 formed on an outer surface of end 3202. The ring 3204 isreceived in a groove 3107, which can be formed on an inside surfaces ofbody halves 3106 and 3108. The mating of ring 3204 in groove 3107permits section 3200 to rotate with respect to body section 3100, whilepreventing translation of section 3200 with respect to body section3100.

Rotating section 3200 can include a collar 3208 which can be gripped byfingers to rotate section 3200. Ring 3400 can be supported at an end ofrotating section 3200 such that Ring 3400 can rotate freely about thelongitudinal axis of the rotating section 3200 independently of theposition of rotating section 3200. Accordingly, the ring 3400 can bealigned to have the same planar orientation as that of ring grips 3318on translating section 3300, regardless of how rotating section 3200 isrotated.

FIG. 48 provides an enlarged schematic cross-sectional illustration ofportions of the translating section 3300 and the rotating section 3200,and FIG. 49 provides an enlarged schematic cross-sectional illustrationof portions of the apparatus which are employed to engage the endcap orendoscope. The translating section 3300 can have a central bore 3342extending the length of the translating section. The central bore 3342is shown including an enlarged bore section 3344 extending along thelength of hub 3316. A shaft 3350 extends through central bore 3342, andsized with respect to bore 3342 and supported in bore 3342 to rotatefreely within bore 3342. The shaft 3350 can extend from a first end3352, to a second end 3354. Second end 3354 can have an enlargeddiameter relative to the remaining length of the shaft 3350, so that thesecond end 3354 can be employed to compress the cylinders 3350.

Referring to FIG. 48, an internally threaded member 3360 is disposed atan end of the hub 3316. The internally threaded member 3360 can be inthe form of a nut having an internally threaded through hole that isgenerally coaxially aligned with respect to central bore 3342 andenlarged bore section 3344. The internally threaded member 3360 is fixedwith respect to translating section 3300.

Rotating section 3200 can include a longitudinally extending internalchannel 3242 which is generally coaxially aligned with respect to bore3342. An externally threaded member 3260 is disposed to slide in bore3242. The member 3260 can be in the form of a screw having anon-circular head 3262, a longitudinally extended external threadedportion 3264, and a longitudinally extending through bore 3266. Throughbore 3266 extends the length of the screw 3260, and can have an internaldiameter sized to receive shaft 3350 therethrough. Through bore 3266 canbe sized such that shaft 3350 may rotate freely with respect to screw3260.

The head 3262 of screw 3260 can have the shape of a regular polygon.Bore 3242 in rotating section 3200 can have a non-circularcross-sectional shape similar to that of the head 3262 (e.g. hexagonalcross-section if head 3262 is hexagonal), so that screw 3260 cantranslate in bore 3242 relative to rotating section 3200, but such thatscrew 3260 is constrained to rotate with rotating section 3200.Alternatively, screw 3260 could have a head 3262 which includes a key orother feature for permitting sliding translation of screw 3260 withinthe bore 3242, while ensuring that screw rotates with rotating section3200.

A shaft collar 3356 is disposed at or near shaft end 3352 of shaft 3350.Shaft collar 3356 can be fixed to shaft 3350, such as with a set screw,pin, adhesive, or any other suitable fastening means for fixing collar3356 on shaft 3350. Collar 3356 can be disposed in bore 3242, and has anouter diameter sized to permit collar 3356 to freely translate androtate with respect to rotating section 3200. A surface 3358 of collar3356 can abut or otherwise engage an end surface of screw head 3262, asshown in FIG. 48.

Referring to FIG. 49, cylinders 3500 can be supported on a portion ofthe shaft 3350 which extends from bore 3342. Cylinders 3500 can besupported on a portion of the shaft 3350 which extends outwardly from anend face 3302 of translating section 3300. One cylinder 3500 can bedisposed on shaft 3350 between shaft end 3354 and a spacer 3352. Spacer3352 is formed of a material which is relatively harder and lessresilient than cylinders 3500, and spacer 3352 can be in the form of ametallic washer. The second cylinder 3500 can be disposed on shaft 3350between spacer 3352 and a pair of spacers 3354. Spacers 3354 can bedisposed on shaft 3350 between the second cylinder 3500 and end face3302, as shown in FIG. 49.

To employ the apparatus 3000 to load an endcap onto an endoscope, theapparatus 3000 is positioned with respect to the endcap and endoscope asshown in FIG. 45, with the translating section 3300 in a forwardposition with respect to the body section 3100, with shaft end 3350 andcylinders 3500 disposed in the working channel of the endoscope; withthe endface 3302 of translating section 3300 against the distal end faceof the endoscope, and with surface 3122 of body section 3100 against thedistal face of the endcap. Rotating section 3200 is then rotated (suchas via collar 3208), which rotation causes screw 3260 to rotate withinnut 3360. As screw 3260 rotates, screw 3260 translates in a rearwarddirection in bore 3242, in accordance with the pitch of the threads onscrew 3260. Rearward movement of screw 3260 pushes shaft collar 3356rearward, which in turn causes the shaft 3350 and shaft end 3354 to moverearward relative to the translation section 3100, thereby compressingthe cylinders 3500 and causing the cylinders to expand radially andcompressively engage the inside surface of the working channel of theendoscope.

Then, with the cylinders 3500 expanded in the working channel of theendoscope, the thumb can be inserted in ring 3400 and two fingers can beinserted in ring grips 3318. The fingers in ring grips 3318 can exert arearward force on translating section 3300 such that section 3300 isdrawn rearward with respect to body section 3100. Drawing thetranslating section 3300 rearward as shown in FIG. 47 (in the directionof arrows 3302) also results in the shaft 3350 and cylinders 3500 movingrearward. Because the shaft 3350 and cylinders 3500 move rearwardtogether with translating section 3300, the cylinders are not expandedfurther. The rearward force on shaft 3350 (tensile force in shaft 3350)and cylinders 3500 (which engage the internal surface of the endoscope)exerts a rearward force on the endoscope (pulling force on endoscope),while surface 3122 on body section 3100 pushes on the distal face of theendcap. Accordingly, as the section 3300 is drawn rearward with respectto body section 3100, a pulling force is exerted on an inner surface ofthe endoscope, while a pushing force is exerted on a distal face of theendcap, thereby urging the endcap onto the distal end of the endoscope.

While the present invention has been illustrated by description ofseveral embodiments, it is not the intention of the applicant torestrict or limit the spirit and scope of the appended claims to suchdetail. Numerous other variations, changes, and substitutions will occurto those skilled in the art without departing from the scope of theinvention. For instance, the device and method of the present inventionhas been illustrated in relation to deployment of a feeding tube throughthe mouth and esophagus, but it will be understood the present inventionhas applicability to other portions of the body, and for instance, couldbe used to direct medical accessories into the body through otheropenings, including other naturally occurring openings in the body.Moreover, the structure of each element associated with the presentinvention can be alternatively described as a means for providing thefunction performed by the element. It will be understood that theforegoing description is provided by way of example, and that othermodifications may occur to those skilled in the art without departingfrom the scope and spirit of the appended claims.

1. An apparatus for positioning a device on an end of an endoscope, theapparatus comprising: a first component for applying a proximallydirected axial force to the device, wherein the first component isconfigured to releasably engage the device; and a second componentoperatively associated with the first component and movable with respectto the first component, wherein the second component is configured toreleasably engage the endoscope, wherein the second component is adaptedto apply a force to an outer surface of the endoscope, and wherein thesecond component is adapted to apply a distally directed axial force tothe endoscope through an opening in the device.
 2. The apparatus ofclaim 1 wherein the first component is adapted to apply a force to thedevice simultaneously with the second component applying the force tothe endoscope.
 3. The apparatus of claim 1 wherein the first componentis adapted to apply a pushing force to the device, and wherein thesecond component is operatively associated with the first component toapply a pulling force to the endoscope simultaneously with theapplication of the pushing force.